Complication, Hospital Stay, Length of Stay in Hospital From Surgery to Discharge, Incisional Hernia, Postoperative Pain, Surgical Site Infection
Conditions
Keywords
Stoma closure, Stoma reversal, Loop ileostomy, Prophylactic mesh, Onlay mesh, Incisional hernia, Abdominal wall reinforcement, Anatomical closure, Randomized controlled trial, Surgical outcomes
Brief summary
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay
Detailed description
Intestinal stomas are used to divert intestinal content as a treatment option. Faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. A stoma may be temporary or permanent according to the condition. Temporary stomas are usually followed by elective stoma closure 6-8 weeks after. Though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications. Incisional hernia following stoma closure occurs in up to 30% of patients. Incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. Other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. Mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (SSIH) with low complications risk. Though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use Mesh-reinforced stoma closure. In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (SSIH),incidence of surgical site infection ,post-operative Pain and Hospital stay
Interventions
DEVICEProlene mesh
Application of mesh onlay post stoma closure
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Neither the participants, the treating surgeons, nor the outcome assessors are blinded to the assigned intervention due to the surgical nature of the procedures.
Intervention model description
Participants are randomized into two parallel groups. The intervention group undergoes stoma reversal with prophylactic onlay Prolene mesh reinforcement, while the control group undergoes standard anatomical closure without mesh. Each participant receives only one assigned surgical technique, and outcomes are compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are fit for aesthesia. * Patients with temporary double barrelled and simple loop ostomy * Patients older than 16 years old
Exclusion criteria
* Patients with end ostomy * Infected stomas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional (stoma-site) hernia rate | Up to 12 months postoperatively | Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-operative Pain | Daily for the first 7 postoperative days | Pain at the stoma closure site measured using the Visual Analog Scale (VAS). |
| Length of hospital stay | through study completion, an average of 2 years | Number of days spent in hospital following surgery. |
| Surgical site infection rate | Within 30 days postoperatively | Rate of postoperative infections at the stoma closure site |
| Operative time | Intraoperative (from skin incision to skin closure) | Total duration of surgery measured in minutes. |
| Intraoperative blood loss | through study completion, an average of 2 years | During surgery |
| Postoperative complications | Within 30 days postoperatively | Any postoperative complications, including wound dehiscence, ileus, bowel obstruction, or reoperation, graded according to Clavien-Dindo classification. |
Countries
Egypt
Outcome results
None listed